Method of treating anal incontinence

ABSTRACT

A method for treating anal incontinence is provided, in which a support member is implanted in a tissue pathway extending from a first location posterior to and adjacent the anus, through the perineum anterior to the anus and terminating at a location posterior to and adjacent the anus opposite the first location.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 12/891,941, filedSep. 28, 2010, entitled “METHOD OF TREATING ANAL INCONTINENCE,” which isa continuation of U.S. Ser. No. 11/428,090, filed Jun. 30, 2006,entitled “METHOD OF TREATING ANAL INCONTINENCE,” now U.S. Pat. No.7,828,715, issued Nov. 9, 2010, which in turn claims priority toprovisional application Ser. No. 60/806,209 entitled “Method of TreatingAnal Incontinence,” which was filed on Jun. 29, 2006, all of whichhereby incorporated by reference in their entireties.

BACKGROUND

Mild anal incontinence, which may present as flatal incontinence and/orfecal incontinence, often results from sphincter muscle damageassociated with childbirth and/or deterioration of the sphincter musclewith age. Patients exhibiting mild anal incontinence also often presentwith pelvic organ prolapse, particularly posterior vaginal wallprolapse, with may result in a descent of the rectum into the vagina,referred to as a “rectocele”.

One surgical method of treating mild anal incontinence is to dissect andidentify the external anal sphincter muscle, and then to bundle andrepair the muscle with end-to-end muscle fibre alignment or“waistcoating” overlap of muscle fibres. These procedures, however, arerelatively invasive and involve significant tissue dissection.Post-operative pain and hospital stays are also associated with thisprocedure.

SUMMARY OF THE INVENTION

In one embodiment, the present invention provides a method of treatinganal incontinence by forming a tissue pathway extending about apatient's anal sphincter, and implanting an elongate flexible supportmember in the pathway and extending about the anal sphincter.

In another embodiment, the method includes the steps of forming left andright buttock incisions in locations posterior to the anus and a vaginalincision, and forming a tissue pathway extending between each incisionand passing through the perineum. This may be accomplished by passing asurgical needle between the left buttock incision and the vaginalincision, and between the right buttock incision and the vaginalincision.

In a further embodiment, the support member is passed through thepathway using a surgical instrument. For example, the surgicalinstrument is passed through one buttock incision to the vaginalincision, is associated with one end of the support member, and thesupport member is passed from the vaginal incision to the buttockincision (or vice-versa). The other end of the support member is passedto the other buttock incision in the same manner. The support member mayalso be tensioned to provide the desired support are the anal sphincter,and may be sutured to various tissues if desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of the rectogenital area of a patient with animplanted support member.

FIG. 2 is a perspective view of a surgical instrument suitable for useto implant the support member shown in FIG. 1.

FIG. 3 is a plan view of the surgical instrument of FIG. 2.

FIG. 4 is a front view of the surgical instrument of FIG. 2.

FIG. 5 is an end view of the surgical instrument of FIG. 2.

FIG. 6 is a perspective view of a support member according to oneembodiment of the present invention.

FIG. 7 is a perspective view of a surgical kit including left and rightelongate surgical instruments as shown in FIG. 2 and a pelvic supportmember as shown in FIG. 6.

FIG. 8 is a schematic view of the rectogenital area of a patientdepicting a perineal incision and left and right buttock incisions.

FIG. 9 is a perspective view of the rectogenital area of a patientdepicting the creation of a right buttock incision.

FIG. 10 is a perspective view of the rectogenital region of FIG. 9depicting the insertion of a surgical guide instrument into a leftbuttock incision.

FIG. 11 is a perspective view of the rectogenital region of FIG. 9depicting further insertion of the surgical guide instrument.

FIG. 12 is a perspective view of the rectogenital region of FIG. 9depicting a support member extending through both buttock incisions.

FIG. 13 is a perspective view of an Apogee™ vault suspension member.

FIG. 14 is a front elevation view of an Apogee™ surgical guideinstrument.

FIG. 15 is a schematic view of a rectogenital region with an implantedsupport member and an implanted Apogee™ vault suspension member.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, the structure of the rectogenital region of afemale patient is schematically depicted with an elongate, flexible,support member 1 in place. The support member 1 is located in andextends along a tissue pathway 10 that has been established in tissue ofthe patient so as to extend about the anal sphincter 101, whichcircumferentially envelops the anal passage extending from the anus 102.The support member 1 is located in a supporting relationship with theanal sphincter 101, so as to provide support for the anal sphincter 101,typically the external anal sphincter, in patients suffering from mildanal incontinence.

In the configuration depicted in FIG. 1, the support member 1 extendsalong the entire length of the tissue pathway 10 about the analsphincter 101 through an included angle of about 300°, as measured aboutan axis extending centrally and perpendicularly through the anus 102.The support member 1 extends approximately between the 7 o'clock and 5o'clock positions of a clockface when viewing the patient in a modifieddorsal lithotomy position, as depicted in FIG. 1. Although theillustrated support member 1 extends through an included angle of about300°, lesser or greater included angles about the anal sphincter 101 areenvisaged. In one embodiment, the support member 1 extends through anincluded angle of at least 180°, and more particularly at least 270°, soas to provide support around a significant portion of the circumferenceof the anal sphincter 101. Embodiments are also envisaged where thesupport member 1 extends a full 360° about the circumference of the analsphincter 101.

In the configuration depicted in FIG. 1, the tissue pathway 10 extendsfrom a left pathway end 10 a lateral and posterior to the anus, throughthe perineum 103 (located between the anterior side of the analsphincter 101 and the posterior vaginal wall 104) and to a right pathwayend 10 b located contralateral (i.e., on the patient's right side) andposterior to the anus 102.

Other configurations extending about the anal sphincter 101 are alsoenvisaged, including an effectively reverse configuration extending froma left pathway end lateral and anterior to the anus, through a regionposterior to the anus, to a right pathway end contralateral and anteriorto the anus 102. Such a pathway might, for example, extend between the 1o'clock and 11 o'clock positions. Rather than extending along thelateral and contralateral sides of the anal sphincter 101, the tissuepathway 10 might alternatively extend from two pathway ends on the samelateral side of the anus 102, passing posterior and anterior to the analsphincter 101, to a central pathway region on the contralateral side ofthe anus 102. The general configuration depicted in FIG. 1 may be themost effective for anal sphincter injuries resulting from childbirth orepisiotomy because such injuries generally occur between the 10 o'clockand 2 o'clock positions.

The surgical procedure to support the anal sphincter 101 may be carriedout using any of various known support sling systems, including slingsused for pubovaginal procedures for stabilising and/or supporting thebladder neck or urethra. Examples of such slings and sling proceduresare disclosed in, for example, U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,309,686; 6,042,534 and 6,110,101 eachof which is incorporated by reference. A variety of slings are alsocommercially available from American Medical Systems, Inc. ofMinnetonka, Minn.

A particularly suitable sling system is disclosed in U.S. Pat. No.6,911,003, the entire contents of which are hereby expresslyincorporated by reference. A commercial embodiment of this system isavailable from American Medical Systems as the Monarc™ subfascialhammock, and is indicated for the treatment of stress urinaryincontinence. The Monarc™ system includes a pair of elongate surgicalguide instruments each including a helically formed needle elementattached to a handle, an elongate flexible support member (referred toas a support sling) and dilator/connectors for attaching the ends of thesupport sling to a tip portion of each needle element. Any of variousother known sling systems may, however, also be suitable for use withthe present pelvic support procedure.

FIGS. 2 to 5 depict an elongate surgical guide instrument 20 disclosedin U.S. Pat. No. 6,911,003 and used in the Monarc™ system. The surgicalguide instrument 20 is particularly suitable for use on the left side ofthe patient's body. A surgical instrument suitable for use on the rightside of the patient's body is configured as a mirror image to thesurgical instrument 20, with the helical portion extending from theshaft portion in an opposing helix to that of the surgical instrument 20designed for left side use. The surgical guide instrument 20 includes aneedle element 21 having a proximal straight shaft portion 22 fixed to aplastic 25. A distal helical portion 23 of the needle element 21 extendsfrom the shaft portion 22 in a generally helical configuration to a tipportion 24. Although the surgical instrument 20 of the Monarc™ system isconfigured to pass between an incision adjacent the anterior side of thepubic bone through the obturator foramen to the posterior side of thepubic bone and to emerge from a vaginal incision, the helical shape isalso suitable for the present procedure. Many other configurations ofsurgical instruments, however, are also envisaged, including, forexample, C-shaped needles and other curved needle configurations. Thespecific configuration of the surgical guide instrument is dependent ona number of factors, including the surgeon's preference and varyinganatomical sizes of patients. Any configuration of surgical guideelement that enables creation of the necessary tissue pathway 10 forplacement of the support member 1 will suffice.

The needle portion 21 is typically formed of a durable, biocompatiblematerial such as, but not limited to, stainless steel, titanium, Nitinolvarious polymers, and combinations of such materials. The needle portion21 is relatively slender and may have a circular cross-sectional shapehaving a diameter of less than 3.5 mm to allow for relatively easypassage of the needle portion 21 through tissue so as to establish thetissue pathway 10.

FIG. 6 depicts an example of a support member 1 suitable for use withthe present procedure in the form of a support sling 1 of the Monarc™system as disclosed in U.S. Pat. No. 6,911,003. The illustrated supportsling 1 is a tape formed from a flexible mesh material. The supportsling 1 may be formed as a single monolithic piece, or a composite ofdifferent components and/or different materials. Suitable syntheticmaterials for forming the support sling 1 include polymers and metallicmaterials and, in the case of the Monarc™ sling mesh, polypropylene. Thesupport sling may alternatively be formed of non-synthetic material.Various suitable synthetic and non-synthetic materials are disclosed inU.S. Pat. No. 6,911,003 and additional suitable materials are known inthe art. In one embodiment the sling material is elastically deformable.The support sling 1 may also incorporate a coating, such as ananti-bacterial coating, to, for example, fight bacterial infection orreduce the chance of sling rejection by the body. The support sling 1may have a generally elongate rectangular shape, as depicted, or anotherelongate shape including, for example, an elongate shape having abroader central region. The Monarc™ system support sling has anunstressed width of approximately 11 mm and length of approximately 350mm.

The support member 1 is provided with a dilator/connector 2 at each ofits first and second ends 1 a, 1 b. As described in U.S. Pat. No.6,911,003, the dilator/connector 2 has an open end with internalsurfaces adapted to engage corresponding external surfaces on the tipportion 24 of the surgical instrument 20, allowing the support sling 1to be readily connected to, and extend between, two surgical instruments20. The external surface of each dilator/connector 2 tapers toward itsfree end. This taper acts to dilate the tissue pathway 10 as it passestherethrough, providing for ease of passage of the support sling 1.Various other forms of dilator and/or connector may, however, beutilised as desired.

A tensioning suture 3 is woven along the length of the mesh materialforming the support sling 1, to assist in tensioning and preciseplacement of the support sling 1, as will be further described below.

The support sling 1 is encased in two protective sheaths 4, extendingfrom the first and second ends 1 a, 1 b of the support sling 1respectively, and overlapping in a central region of the support sling1. The sheaths 4, which are again further described in U.S. Pat. No.6,911,003, are typically formed of plastic material, such aspolyethylene.

FIG. 7 depicts a surgical kit including a left surgical guide instrument20, right surgical guide instrument 20′ and support sling 1. The supportsling 1 is connected to the tip portion 24 of the left surgical guideinstrument 20 by the dilator/connector 2. The sheaths 4 act to protectthe support sling 1 during the surgical procedure, and assist in passageof the mesh material of the support sling 1 through the tissue pathway10.

Suitable implantation procedures can be carried out under local orgeneral anesthesia. The patient should be placed in a modified dorsallithotomy position with hips flexed, legs elevated in stirrups, andbuttocks even with the edge of the table. Vaginal retraction using aweighted vaginal retractor or other means may be utilized if desired. Asshown in FIG. 8, the tissue pathway 10 for location of the support sling1 is established by first making three incisions, a vaginal incision 11,a left buttock incision 12 and a right buttock incision 13.

Vaginal incision 11 extends into the perineum 103, and will typically bea transverse incision of approximately 40-50 mm in length, and may bemade in the posterior vaginal wall 104 at or adjacent the posteriorvaginal vestibule/hymen ridge 105. The posterior vaginal wall 104 may befurther dissected superior and inferior from the vaginal incision 11 soas to expose the perineal body 106 (the central tendon of the perineum103). Alternatively, an incision could be made directly into theperineum 103 in a location posterior to the vaginal wall 104.

Referring to FIGS. 8 and 9, a right buttock incision 13 of approximately3 mm in length is made at a position corresponding to the right pathwayend 10 b, lateral and posterior to the anus 102, in the right buttock.The right buttock incision 13 may be made approximately 3 cm lateral tothe anus 102 and 3-4 cm posterior. This position is approximately at the7 o'clock position when viewing the patient in the modified dorsallithotomy position. A left buttock incision 12 is made in thecorresponding position on the contralateral side, corresponding to theleft pathway end 10 a. The precise location of the left and rightbuttock incisions 12, 13 may vary according to surgeon preference.

A left passage 14 of the tissue pathway 10 is established between theleft buttock incision 12 and the vaginal incision 11, using the leftsurgical instrument 20. The left surgical instrument 20 is inserted intothe left buttock incision 12 with the needle tip portion 24 leading,gripping the handle 25 with the right hand. Referring to FIG. 10, theleft surgical instrument 20 is oriented such that the needle tip portion24 is oriented generally perpendicular to the skin at the left buttockincision 12.

Referring to FIG. 11, the needle tip portion 24 is pushed deeper intothe left buttock incision 12, puncturing the initial layers of tissueincluding the ischiorectal fossa and/or the perianal tissue adjacent tothe ischiorectal fossa. The needle tip portion 24 should be advanced inthis direction, a distance of approximately 2-3 cm. Whilst the needletip portion 24 is being advanced, the surgeon's left index finger shouldbe inserted into the patient's anal canal, primarily as a protectivemechanism, to ensure that the needle tip portion 24 does not puncturethe anal canal. The finger can also serve as a guide, palpating thelocation of the needle tip portion 24 as it advances.

The left surgical instrument 20 is then rotated, utilizing the helicalconfiguration of the needle element 21 to direct the needle tip portion24 towards the outside lateral edge of the perineal body 106 andsuperior to the perineal body 106. The needle tip portion 24 is advanceduntil it is displayed in the opening created by the vaginal incision 11and dissected. As the left surgical instrument 20 is advanced to thisposition, the left index finger may be used to gently pull the analcanal away from the advancing needle element 21, thereby furtherensuring integrity of the anal canal is maintained.

The right surgical instrument 20′ is taken by the surgeon and the rightpassage 15 of the tissue pathway 10 is established by the same procedureas discussed above, guiding the needle tip portion 24′ of the rightsurgical instrument 20′ through the right buttock incision 13 to thevaginal incision 11, with the surgeon's right index finger inserted inthe anal canal.

The support sling 1 is then connected to the left and right surgicalinstruments 20, 20′ by snapping the dilator/connectors 2 at each end 1a, 1 b of the surgical sling 1 onto the needle tip portions 24, 24′ ofthe left and right surgical instruments 20, 20′ respectively. At thisstage, the protective sheaths 4 are left in place over the support sling1. Both surgical instruments 20, 20′ are then pulled back through theleft and right passages 14, 15 respectively, drawing thedilator/connector 2 and ends 1 a, 1 b of the support sling 1 through theleft and right passages 14, 15 and out of the left and right buttockincisions 12, 13. The support sling 1 is thus located extending alongthe tissue pathway 10 from the left buttock incision 12, through theperineum 103 and out of the right buttock incision 13.

The surgical instruments 20, 20′, which are now located entirely on theexterior of the patient's body, are removed from the surgical sling 1 bycutting through the sheaths 4 and surgical sling 1 adjacent thedilator/connectors 2.

Referring to FIG. 12, the surgical sling 1 and overlying protectivesheaths 4 are then manually adjusted into the desired position. Thesupport sling 1 should be located sufficiently close to the analsphincter 101 to provide support, but should not impart any appreciableload on the anal sphincter 101 that would tend to constrict or kink theanal canal.

To draw the surgical sling 1 taut and closer to the periphery of theanal sphincter 101, tension may be applied to each opposing end of thetensioning suture 3 extending along the length of the mesh tape formingthe surgical sling 1. With the surgical sling 1 now in the desiredposition, the protective sheaths 4 may be removed by pulling themthrough the left and right passages 14, 15 respectively, through theleft and right buttock incisions 12, 13.

Once the desired position of the surgical sling has been achieved, thesurgical sling 1 may be sutured to the perineal body 106, typically atlateral and contralateral positions, so as to securely fix the surgicalsling 1 in the desired position. The sutures may be absorbable, oralternatively may be non-absorbable. The surgical sling 1 is trimmed atthe level of the subcutaneous tissue at the left and right buttockincisions 12, 13. The left and right buttock incisions 12, 13 andvaginal incision 11 and dissection are then closed.

Although the above described procedure utilizes an “outside-in” approachto establish the passages 14, 15 of the tissue pathway 10, an“inside-out” approach may alternatively be utilized. In such anapproach, a modified form of a surgical guide instrument having adetachable handle, an example of which is again disclosed in U.S. Pat.No. 6,911,003, may be utilized. The needle elements of these alternatesurgical instruments are passed from the vaginal incision 11 to the leftand right buttock incisions 12, 13 to establish the left and rightpassages 14, 15 with the handles attached to a first end of the needleelement extending through the vaginal incision 11. The handles are thenremoved from the first end of each of the needle elements, and attachedto the opposing second end of the needle elements, which at this stageof the procedure extend through the buttock incisions. The surgicalsling is then connected to the first end of the needle elements anddrawn through the left and right passages by again drawing the needleelements back through the passages. If desired one passage could beformed by the “outside-in” approach, and the other by the “inside-out”approach.

In a further embodiment, a single passage extending from the leftbuttock incision 12 to the right buttock incision 13, via the perineum103, could be formed by utilizing a single needle that extends throughthe entire pathway. This embodiment would eliminate the need for theperineal incision and/or one of the buttock incisions.

If the surgeon desires to create the tissue pathway with a differentconfiguration (such as, for example, between the 1 o'clock and 11o'clock positions), alternate incisions may be required to establish thetissue pathway. For example, for a 1 o'clock to 11 o'clockconfiguration, a first incision would be made anterior and lateral tothe anus, a second incision contralateral and anterior to the anus and athird central incision made posterior to the anus between the buttocks.Such a tissue pathway may also be established by a single passage,omitting the need for the central posterior incision.

Given that many patients suffering from mild anal incontinence alsoexperience pelvic organ prolapse, it will often be beneficial to conductthe above described pelvic support procedure together with a procedureto treat the pelvic organ prolapse. A particularly suitable system andtreatment for pelvic organ prolapse is described in US PatentApplication Publication No. US 2005/0245787 A1, the entire contents ofwhich are hereby expressly incorporated by cross-reference. A commercialembodiment of this system is available from American Medical Systems,Inc. as the Apogee™ Vault Suspension System. The Apogee™ system includesa support sling and surgical guide instrument.

An example of an Apogee™ support sling is depicted in FIG. 13. Thesupport sling 30 includes first and second elongate mesh tapes 31supporting a central support element 32, commonly referred to as a cape,which extends above and below the points of attachment of the mesh tapes31, to form a superior cape flap 33 and an inferior cape flap 34. Thecape 32 is formed of a mesh material, similar to the mesh tapes 31.Versions of the Apogee™ system are also available without the cape 32,with the support sling being in the form of a continuos mesh tape, and afurther version is available utilizing what is referred to as bio-cape.The free ends 31 a of the mesh tapes 31 are provided withdilator/connectors 35 for attachment to a surgical needle.

Referring to FIG. 14, a surgical guide instrument 40 of the Apogee™system includes a curved needle element 41 and a handle 45. A tipportion 44 of the needle element 41 has a cooperating connectorstructure for engaging the dilator/connectors 35 of the sling support30. Although this Apogee™ system is particularly suitable for treatingpelvic organ prolapse, other pelvic organ prolapse repair systems may beutilized as desired.

When carrying out a pelvic organ prolapse treatment such as the Apogee™procedure in combination with the previously described anal supportprocedure, the procedure is carried out with certain modifications.

First, the buttock incisions for establishing the tissue pathway forimplanting the Apogee™ support sling, which would normally be adjacentto or above the buttock incisions for the anal support procedure, aremade further lateral and posterior, as indicated in FIG. 15. Forexample, the left and right buttock incisions 52, 53 for the Apogee™procedure may be located approximately 2 cm lateral and 3-4 cm posteriorto the left and right buttock incisions 12, 13 formed for the pelvicsupport procedure. The surgical guide instrument 40 is then used toestablish the left and right passages of the tissue pathway for theApogee™ procedure following the same general path as described in USPatent Application Publication No. 200510245787 A1, in front of theischial spine, through the levator muscle and to the incision anddissection to the posterior vaginal incision and dissection created forplacement of the cape. This tissue pathway extends lateral and superiorto the tissue pathway 10 of the present pelvic support procedure. Thevaginal dissection for placing the cape will extend from the initialvaginal incision for the Apogee™ process (located superior to thevaginal incision 11), down to the vaginal incision 11. As the inferiorflap 34 of the cape 32 of the Apogee™ support sling 30 typically extendsdown to a position adjacent the perineal body 106, the inferior flap 34may be sutured to the perineal body 106 with the same lateral andcontralateral suturing performed during the pelvic support procedure tosecure the pelvic support sling 1 to the perineal body 106. This mayimprove the fixation of the Apogee™ cape 32, which would otherwise berelatively loosely located within the soft tissue of the posteriorvaginal wall.

The person skilled in the art will appreciate that the above describedprocedures may be varied as desired by the surgeon, depending onpersonal preferences, anatomical size of patient, and specific patientsymptoms. The above described procedures may also be carried oututilizing a variety surgical support sling kits in addition to theMonarc™ and/or Apogee™ systems referred to above. The pelvic supportprocedure could also be carried out on male patients suffering from mildanal incontinence, and both male and female patients suffering from urgefecal incontinence.

The invention claimed is:
 1. A method of treating anal incontinence in apatient comprising: providing an elongate flexible support member havingtwo opposed ends, a flexible tape extending between the two opposedends, the flexible tape forming a central portion and two elongateextension portions between the two ends; establishing a pathway intissue of the patient extending about the patient's anal sphincter andextending into the patient's perineum, comprising the steps of making aleft buttock incision in the patient's left buttock at a left pathwayend, making a right buttock incision in the patient's right buttock at aright pathway end, making an incision in a posterior vaginal wall thatextends into the perineum, establishing a left passage of said pathwayextending between said left buttock incision and said vaginal incision,and establishing a right passage of said pathway extending between saidright buttock incision and said vaginal incision, wherein said pathwayextends from the left pathway end, through the perineum, to the rightpathway end; and implanting the elongate flexible support member in andextending along said pathway to support the anal sphincter.
 2. Themethod of claim 1 wherein said support member extends about the analsphincter through an included angle of at least 180°, measured about anaxis extending centrally through the anus.
 3. The method of claim 1wherein said support member extends about the anal sphincter through anincluded angle of at least 270°, measured about an axis extendingcentrally through the anus.
 4. The method of claim 1, wherein: the stepof establishing said left passage comprises passing an elongate surgicalinstrument between said left buttock incision and said vaginal incision;and the step of establishing said right passage comprises passing anelongate surgical instrument between said right buttock incision andsaid vaginal incision.
 5. The method of claim 4, wherein the step ofimplanting said support member comprises: securing a first end of saidsupport member to an elongate surgical instrument; drawing said elongatesurgical instrument and said first end of said support member throughsaid left passage; and securing a second end of said support member toan elongate surgical instrument; and drawing said elongate surgicalinstrument and said second end of said support member through said rightpassage.
 6. The method of claim 5 further comprising the step ofsuturing said support member to the perineal body.
 7. The method ofclaim 1 further comprising the step of tensioning said support member soas to locate said support member in a desired position relative to theanal sphincter.
 8. The method of claim 1 wherein said support member isformed of a flexible mesh material.
 9. The method of claim 1 furthercomprising the step of implanting a pelvic organ prolapse device in thepatient.
 10. The method of claim 1 comprising the step of suturing saidsupport member to the perineal body.
 11. The method of claim 1 whereinthe central portion extends between an anterior side of the analsphincter and the posterior vaginal wall.
 12. The method of claim 1wherein the central portion is not positioned to contact vaginal tissueas part of a procedure to treat vaginal prolapse.
 13. The method ofclaim 1 wherein the support member consists of the flexible tape forminga central portion and two elongate extension portions between the twoends.
 14. A method of treating anal incontinence in a patientcomprising: forming a first incision in a buttock of the patientposterior to the anus; forming a second incision in an opposite buttockposterior to the anus; forming a vaginal incision in the posteriorvaginal wall; forming a tissue pathway between the first and secondincisions by passing a surgical instrument between the first incisionand the vaginal incision, and between the second incision and thevaginal incision; and implanting a support member in the tissue pathwaysuch that the support member is positioned around at least 180 of thecircumference of the anal sphincter; wherein the support membercomprises two opposed ends, a flexible tape extending between the twoopposed ends, the flexible tape forming a central portion and twoelongate extension portions between the two ends.
 15. The method ofclaim 14 further comprising the step of suturing said support member tothe perineal body.
 16. The method of claim 14 wherein the support memberconsists of the flexible tape forming a central portion and two elongateextension portions between the two ends.